Associate Director, Centralized Compliance Services

Johnson & Johnson•Raritan, NJ

54d

About The Position

Johnson & Johnson is currently recruiting for Associate Director, Centralized Compliance Services! This position can be located in Raritan, NJ, Horsham, PA or Beerse, Belgium. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): North America- Requisition #R-044264 Beerse Belgium-Requisition# R-045004 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Position Summary: The Associate Director, Centralized Compliance Services has end-to-end leadership responsibility for centralized services, capabilities, and strategies supporting Technology Regulatory Compliance (TRC) functional effectiveness, including ownership, management and execution of Johnson & Johnson Technology Services (JJT-TS) and Enterprise Quality (EQ) core compliance programs for Regulatory Standards Management, Inspection Support and JJT-TS Inspection Readiness. The position will be responsible for providing inputs to TRC risk assessment processes and informing future state audit processes based on data-driven analysis. This position will partner with JJT-TS, EQ and business Segments to ensure that J&J Quality Standards and global regulatory requirements are met and will drive integration of new or changing regulations into the JJT-TS QMS and operational processes, including monitoring implementation status. This position maintains awareness of the external regulatory landscape and is responsible for external regulatory outreach to shape emerging regulations in the areas of technology and innovative healthcare solutions. This position drives compliance metrics analysis and communication of risk themes to drive systemic actions when appropriate. This position owns the Inspection Readiness program for JJT-TS, including Data Center Inspection Readiness and direct support to business segments during Health Authority and other Third-party audits related to technology areas. The position is also responsible for compliance metrics analysis and communication of risk themes related to inspections to drive systemic actions when appropriate. Responsibilities include portfolio and program management for TRC Compliance Programs; lifecycle management of TRC functional systems and deployment of new digital solutions. This will also include establishing strategies and methods to support a knowledge sharing culture that enhances talent capabilities, including future readiness, retention, pipeline growth. This role provides GxP compliance support to base business and innovation initiatives, including, but not limited to, emerging healthcare technology such as RPA, Digital Products, AI/ML, etc. This position reports solid line to the Head, JJRC Technology Regulatory Compliance within the Johnson and Johnson Regulatory Compliance (JJRC) organization.

Requirements

A minimum of a Bachelors or University degree is required with a focus science, IT, engineering, business or QRC discipline is highly preferred
7+ years of experience in managing all aspects of Quality and Regulatory Compliance in an international, global context, in a regulated healthcare environment.
Minimum of 2 years of experience in information systems auditing within Pharmaceutical/Medical Device company or 3 years of direct experience with development, implementation and/or validation of computerized systems within Pharmaceutical/Medical Device company.
Expert knowledge of Quality System regulations, ISO, ICH, PIC/S, and cGMP regulations, including Annex 11, 21 CFR Part 11, Part 210, Part 211 and Part 820, and how these apply to Computer Systems.
Expert knowledge of IT internal controls, SDLC methodologies, GAMP5, data integrity requirements.
Experience supporting health authority inspection activities.
Experience interpreting regulations and translating regulatory requirements into practical strategies.
Ability to resolve complex regulatory compliance issues.
Ability to analyze and interpret technical journals and legal documents.
Proven success in strategy development.
Excellent written and oral communication skills, including proven ability to make technical and complex topics clear and easily understood orally and in writing.
Ability to perform work independently and proven experience in driving progress.
Ability to effectively present information to executive management.
Ability to lead teams and build strong cross-functional relationships.
Ability to influence, negotiate, and build credibility.
Strong skills in interdependent partnering to facilitate collaboration.
Audit management and delivery
In-depth and up-to-date compliance knowledge
Stakeholder and team coordination
Analytical mindset

Nice To Haves

Preferred candidate will have advance auditing skills with demonstrated aptitude for auditing Information Systems and associated processes.
Ambition/desire to learn and upskill on technologies supporting Industry 4.0, Quality 4.0, and digital health
Understanding of medical device software quality requirements, including standards for medical device software development and risk management preferred.
Data analysis and reporting
Risk-based audit framework development and execution
Audit logistics coordination

Responsibilities

Compliance Programs Ownership - - Standards Management, Inspection Support and JJT-TS Inspection Readiness (50%)
Owns the Regulatory Standards Management program for Enterprise Quality. Partners with Technology Services and Enterprise Quality to execute gap assessments between current practices and new/changing regulatory expectations, and ensures integration of changes into business processes, including monitoring of implementation status. Facilitate quarterly meetings with Standards Council, including formal documentation of meeting minutes in QMS. Manage notification and formal escalation process regarding uncovered gaps and remediation steps.
Partners with TRC Operations and contributes content for the development of schedules and resourcing.
Negotiate alignment and secure support for audit and gap assessment remediation actions across Sector and functional groups.
Provides compliance SME inputs to TRC risk assessment process to ensure complex risk factors associated with technology are incorporated into the framework.
Owns and lead Technology Services Health Authority inspection readiness program, including authoring procedures, supporting data center and site readiness, front room and back-room management, and Subject Matter Expert (SME) preparation.
Engage directly with health authority inspectors from regulatory agencies on matters related to IT processes, computer system validation, and other technical topics and assist/accompany technical subject matter experts to engage with regulators as needed.
Owns Health Authority inspection support program for segments, including intakes from process areas across Innovative Medicine, MedTech, and Technology Services (TS), and managing inspection request with key stakeholders from JJT-TS and EQ. Ensures continuous expansion of program to cover emerging areas, such as medical device software development and digital health.
Ensures timely and effective support is provided to J&J Operating Companies globally, including working with inspection site leadership to understand Technology Services and Technology Quality related inspection requests, strategizing an approach for regulatory interactions and preparing technical subject matter experts to speak with investigators.
Provides expertise in interpreting and evaluating risk associated with inspection findings and provides direction and p compliance input and final review of formal responses to health authority observations related to Technology Services and/or Technology Quality.
Leads the development and delivery of education and training on inspection process, lessons learned and key takeaways to key stakeholders.
Leads communication efforts for inspection engagement to key stakeholders.
When applicable, leads and/or supports the delivery of education and training on compliance requirements, procedures and controls.
Compliance Program Management - (20%)
Leads TRC PMO and program management for a multi-year Technology compliance roadmap covering process digitalization and automation; compliance program evolution; talent development; and knowledge management.
Serves as central owner of compliance program procedures and templates, including closed loop internal audit, supplier audit, and periodic review, to drive simplification and consistency across programs, while ensuring input from peers and stakeholders is considered and programs are aligned with J&J Regulatory Compliance direction and industry expectations.
Provides strategic direction on adoption of new digital solutions in support of innovation across the enterprise with focus on TRC and owns lifecycle management of TRC audit management systems, including deployment of new features/capabilities.
Maintains knowledge and status of TRC strategic initiatives and major programs and serves as the primary point of contact, and in an advisory capacity to the Head of TRC for all strategic and key operational matters related to the function.
Understands JJRC, EQ, and JJT-Technology Services organizational strategies and integrates requirements into TRC G&O planning and roadmap to ensure alignment.
Drives strategies and practices to establish a knowledge sharing culture that supports talent capabilities, including future readiness and retention. This includes targeted technical and business process trainings, guided learnings, compliance retrospectives, new/changing regulatory Guidances/positions/enforcement trend debriefs, and allocation of talent with specific development/exposure goals (e.g. SaMD, Cybersecurity, etc.) for "ride along or second chair" as part of the Demand & Supply Intake Process.
Leads talent pipeline efforts focused on identifying internal and external candidates with a niche skillet in compliance and technology for future TRC roles.
External Advocacy (20%)
Leads the monitoring efforts for external global regulatory environment for new or changing regulatory requirements and enforcement trends (warning letters or global equivalent) related to IT systems, data integrity, and Health Tech areas such as SAMD, AI/ML, RPA, etc. to remain up-to-date with new compliance regulations and technology developments
Maintain an in-depth knowledge of Health Authority regulations which could impact the global portfolio of computerized systems used in Supply Chain, Manufacturing, Laboratory, Commercial and R&D.
Partners with JJRC-Enterprise Regulatory Outreach and owns strategic direction of Technology related regulatory outreach and associated activities to ensure alignment with business priorities.
Leads engagement and advocacy efforts for J&J's position within the regulatory landscape where appropriate by providing commentary or guidance to third party regulating bodies and external organizations when requested
Interprets and communicates current and emerging regulations at a global level and continuously monitors the changing regulatory climate to proactively assess and communicate trends and emerging areas. Leads awareness efforts for regulatory developments within TRC, EQ and JJRC.
Participates in industry and other professional networks to ensure awareness of industry standards, trends and best practices in order to strengthen GxP audit knowledge. Engages with industry groups (e.g., ISPE, AdvaMed) to understand and influence the external regulatory environment.
Stakeholder Management, Compliance Expertise and Support for Innovation Initiatives (10%)
Provides partnership, insight, and direction to cross-functional business leaders and stakeholders regarding TRC processes, capabilities, and initiatives.
Build and implement a relationship management plan to maintain consistent touchpoints with process area stakeholders, business owners, and EQ leads.
Partners with stakeholders to assess, develop and implement solutions that enable compliant innovation. Identifies potential risks, articulates impact, and gains alignment from business partners to establish proactive risk mitigation strategies.
Serves as Subject Matter Expert to JJT-TS, EQ and JJRC Segment Leaders with regards to innovative technology initiatives
Partners with Technology Services, Enterprise Quality and Business Quality groups to execute gap assessments between current practices and new regulatory expectations, as communicated via new health authority regulations, guidances, and enforcement trends. Works with Quality partners to establish corrective actions to address any identified gaps.
Works with key stakeholders to develop meaningful comments to proposed regulation and guidances.

Benefits

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours
Additional information can be found through the link below.
https://www.careers.jnj.com/employee-benefits

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